Consumer Information for: CONTINGENCY ONE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

CONTINGENCY ONETM is an emergency or backup contraceptive.

CONTINGENCY ONETM can prevent pregnancy after a contraceptive accident (such as a broken condom) or when no form of birth control was used. Treatment is most effective if used in the first 72 hours (3 days) following unprotected sex.

CONTINGENCY ONETM cannot terminate an existing pregnancy. Although there is no scientific evidence that CONTINGENCY ONE would harm a developing embryo, women who are already pregnant should not use this product.

CONTINGENCY ONETM should not be used in place of regular contraception. It does not work as well as most other contraceptives used correctly.

What it does

CONTINGENCY ONETM acts as an emergency contraceptive by preventing the release of an egg from the ovary, or preventing sperm and egg from uniting. In addition, CONTINGENCY ONETM may prevent the fertilized egg from attaching to the wall of the uterus. CONTINGENCY ONETM is not effective once a pregnancy has started, that is once the fertilized egg has attached to the wall of the uterus. CONTINGENCY ONETM does not cause an abortion.

CONTINGENCY ONETM can be used following any unprotected act of sexual intercourse, including:

  • When no contraceptive has been used
  • When a contraceptive method may have failed, including:
    • Condom rupture, slippage, or misuse
    • Diaphragm or cap dislodgment, breakage or early removal
    • Failure to withdraw before ejaculation
    • Miscalculation of the fertile period by women practising periodic abstinence
    • IUD expulsion
    • Missed oral contraceptives
    • A delay in starting a new packet of oral contraceptives
    • A delay in getting a scheduled contraceptive injection
  • In cases of sexual assault (rape)
When it should not be used

Do not use CONTINGENCY ONETM if:

  • you have a confirmed or suspected pregnancy
  • you are allergic to Levonorgestrel, or to any ingredient in the formulation (see list of nonmedicinal ingredients below)
  • you have abnormal vaginal bleeding
What the medicinal ingredient is

Levonorgestrel

What the non-medicinal ingredients are

Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and polyvinyl pyrrolidone K-25.

What dosage form it comes in

The package contains one tablet, containing 1.5 mg of levonorgestrel. The tablet is round, white to off-white, uncoated, flat faced beveled edge debossed with 251 on one side and other side plain.

Warnings and precautions

Serious Warnings and Precautions

  • CONTINGENCY ONETM provides no protection against HIV/AIDS and other sexually transmitted diseases (STDs), such as syphilis, gonorrhoea, chlamydia, and herpes. If you are worried about whether you may have been infected with HIV/AIDS, or other sexually transmitted diseases, talk to your health professional about your concerns and ask how you can protect yourself in the future.
  • If your period is delayed more than 1 week, you should contact your doctor and have a pregnancy test done.

CONTINGENCY ONETM is for Emergency Contraceptive Use Only and should not be used on a regular basis. CONTINGENCY ONETM is not as effective in preventing pregnancy as most other birth control methods (e.g. oral contraceptive pills, IUDs, implants or condoms, etc.). It should not be relied on for routine birth control by sexually active women.

CONTINGENCY ONETM provides only short-term protection against pregnancy. Sexual activity that takes place later can still result in pregnancy if no contraceptive is used. You must abstain from sex or use another barrier method of birth control until your next normal period to make sure you do not get pregnant.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some data that levonorgestrel may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. If you have any questions regarding this, please consult with a health care professional.

BEFORE you use CONTINGENCY ONETM, talk to your doctor or pharmacist if you have now or have previously had any of the following conditions:

  • Unusual vaginal bleeding that has not yet been diagnosed
  • Known or suspected breast cancer
  • Active liver disease or tumour
  • You have diabetes
  • You have high blood pressure
  • You are pregnant or breast feeding
Interactions with this medication

Before you use CONTINGENCY ONETM, talk to your doctor or pharmacist if you are taking any of the following drugs:

Drugs that may decrease the efficacy of CONTINGENCY ONETM include:

  • anti-HIV drugs (efavirenz, ritonavir)
  • anticonvulsant drugs (phenytoin, carbamazepine, primidone, phenobarbital)
  • antibiotics (ampicillin, cotrimoxazole, tetracycline, temafloxacin, clarithromycin)
  • rifampicin
  • rifabutin
  • griseofulvin
  • Hypericum perforatum (St. John’s wort)
  • ulipristal acetate

If your period is delayed more than 1 week and you were taking any of these medications, you should contact your doctor or pharmacist and have a pregnancy test done.

Tell your doctor if you have taken CONTINGENCY ONETM within 3 days of a Pap test, as it may affect your results.

Proper use of this medication

Usual Dose

CONTINGENCY ONETM can prevent pregnancy if the tablet is taken within 72 hours (3 days) and preferably within 12 hours after a contraceptive accident or unprotected sex (sex without birth control). Do not delay starting treatment. CONTINGENCY ONETM is more effective the sooner you start after unprotected intercourse.

CONTINGENCY ONETM can be taken with a glass of water.

If you vomit within 2 hours of taking CONTINGENCY ONETM, call your doctor or pharmacist as you might need another dose.

Important: If more than 72 hours (3 days) have passed since unprotected sex occurred, CONTINGENCY ONETM may not be effective. See your health professional as soon as possible to discuss other options.

Although the risk of pregnancy is highest in the middle of the menstrual cycle (possibly as early as day 10 after the beginning of your last period), pregnancy can occur at other times during the menstrual cycle. CONTINGENCY ONETM can be administered anytime during your monthly cycle if you are worried about an unwanted pregnancy.

The treatment does not bring on menstruation. You may experience spotting a few days after taking CONTINGENCY ONETM, but this is not a period. Your next menstrual period should come on time (or a few days early or late). If your period is delayed more than a week or if you have any other cause for concern, talk to a health professional. More than occasional use (more than once in a menstrual cycle or more than once a month) may upset your menstrual cycle (period).

If you are sexually active and do not wish to become pregnant, you should use a reliable method of contraception on a regular basis. If you want more information about regular contraceptives or if you are having trouble using a method, ask your health professional for help in choosing a method that works for you.

Overdose

If you think you have taken too much CONTINGENCY ONETM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Symptoms of overdose may include nausea, vomiting, vaginal bleeding, and may lead to menstrual cycle disturbances.

Side effects and what to do about them

CONTINGENCY ONETM can cause temporary side effects in some women. These side effects generally do not last more than 24 hours. Common side effects include:

  • Nausea: This occurs in about 14 to 23% of women taking levonorgestrel tablets.
  • Abdominal pain: This occurs in about 18% of women taking levonorgestrel tablets.
  • Fatigue: This occurs in about 17% of women taking levonorgestrel tablets.
  • Headache: This occurs in about 17% of women taking levonorgestrel tablets.
  • Dizziness: This occurs in about 11% of women taking levonorgestrel tablets.
  • Breast tenderness: This occurs in about 11% of women taking levonorgestrel tablets.
  • Vomiting: This occurs in about 6% of women taking levonorgestrel tablets.
  • Diarrhea: This occurs in about 5% of women taking levonorgestrel tablets.
  • Irregular menstrual bleeding: Some women may experience spotting after taking CONTINGENCY ONETM. The majority of women will have their next menstrual period at the expected time or early. When CONTINGENCY ONETM is used repeatedly (more than once in a menstrual cycle, or more than occasional once a month use), menstrual changes may occur, including a shorter or longer cycle and a heavier or lighter period than normal.

Less common side effects: Migraine or severe headache, lower abdominal pain, painful menstruation and vaginal discharge. If the symptoms continue for more than 48 hours or are severe, see your health professional.

Delayed menstrual period: If your period is delayed more than 1 week, you should contact your doctor or pharmacist and have a pregnancy test done.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Call your doctor immediately if the following symptoms and signs of serious adverse effects occur:

  • Itching and rash
  • Cramping or severe pain in your stomach or belly prior to your next normal period, since this can be a warning sign of tubal (ectopic) pregnancy – a serious medical problem
  • Uterine hemorrhage
  • Vaginal hemorrhage
How to store

Store CONTINGENCY ONETM tablet between 15°C and 30°C (59-86 °F). Protect from high humidity.

Keep out of reach of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor,
Mylan Pharmaceuticals ULC at: 1-844-596-9526

This leaflet was prepared by Mylan Pharmaceuticals ULC Etobicoke, Ontario M8Z 2S6

Last Revised: March 9, 2018

Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844-596-9526
www.mylan.ca

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